Development and performance of a next generation sequencing (NGS) assay for monitoring of dd-cfDNA post solid organ transplantation.
Linnéa Pettersson, Sofia Westerling, Venkat Talla...
https://pubmed.ncbi.nlm.nih.gov/37951377Actively Recruiting
Age: 18Years +
All Genders
ID07006831
A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
Led by Devyser Inc. · Updated on 2025-12-17
400
Participants Needed
6
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on kidney transplant patients to collect blood samples and clinical data for developing a non-invasive test that detects donor-derived cell-free DNA (dd-cfDNA) to assess the condition of transplanted kidneys. The study is prospective and multicenter, involving participants who have had a kidney transplant and are undergoing an indication biopsy. The goal is to improve monitoring of the transplanted organ's status. Participants will provide whole blood samples at the time of their indication biopsy, before the biopsy procedure itself. Additionally, leftover de-identified retrospective genomic DNA (gDNA) samples from the kidney donors will be collected for paired analysis. This approach helps researchers study dd-cfDNA in a real-world transplant population. Participants will be involved through blood sample collection and clinical data gathering during their biopsy visits. Researchers will monitor the detection of donor-derived cell-free DNA in whole blood over an 18-month period. The study involves no investigational treatments, focusing on observation and sample analysis. Participation duration and follow-up details align with the biopsy schedule and sample collection requirements.
CONDITIONS
Brief Title
A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Is 18 years of age or older at enrollment
- Had a kidney transplant prior to enrollment
- Is having an indication (for cause) biopsy as determined by clinician
- Retrospective leftover samples are available from the kidney donor(s)
You will not qualify if you...
- Is pregnant
- Had a blood transfusion within the past 4 weeks
- Had a transplant from an identical (monozygotic) twin
- Had transplants of multiple organs from the same donor (eg, kidney and liver transplant)
- Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant)
- Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - At biopsy time
Participants provide whole blood samples and clinical data at the time of an indication biopsy.
1 visit (in-person)
Long-term Monitoring
Duration - 18 months
Participants' donor-derived cell-free DNA levels are monitored over 18 months.
Trial Site Locations
Total: 6 locations
1
Scripps Health
San Diego, California, United States, 92037
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
Actively Recruiting
4
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
5
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Loading map...
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here